Job Description :

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.

Discover Impactful Work:

The Associate Manager Safety Data and PV Systems will lead deliverables for GPS (Global Patient Safety) Safety Data Management and Safety System Maintenance activities. They should provide high quality data outputs for Safety Signal Management, Risk Management and Safety Evidence generation and will collaborate and co-create with client functions and applicable vendors as required for seamless GPS Safety Data and Systems operations.

A day in the Life:

Manages and monitors applicable GPS mailboxes including unblinded data
Serve as the key technical resource for the configuration, maintenance, and administration of the Oracle Argus Safety system.
Support day-to-day operation and troubleshooting of Argus Safety application to ensure reliable and compliant drug safety case processing.
Assist in system validation, testing, and deployment of Argus Safety system updates, workflows, and business rules.
Generate, validate, and customize safety reports and analytics using Argus reporting tools and associated business intelligence platforms.
Collaborate closely with the pharmacovigilance, clinical, and regulatory teams to ensure safety data management aligns with global regulatory standards (FDA, EMA, PMDA, ICH).
Participate in change management processes to enhance Argus Safety system workflows and system integrations.
Contribute to audit readiness activities, including system inspections, validation reports, and compliance documentation.
Collaborates with internal systems team, BIS and Safety vendor on issues related to Safety database configurations
Performs the generation and quality control of aggregate reports and line listings
Initiates and contributes to the development of procedural documents including but not limited to Safety Management Plans, SOPs, work instructions, job aides, forms, or templates
Collaborates and co-creates with applicable client functions (e.g. Medical Information, Data Management, Business Information Systems, Quantitative Science) in regards to pharmacovigilance technical aspects, setup and operation
Keeps up-to-date on applicable regulatory and PV tech guidelines and shares within GPS and client as applicable.
Participates in training related to safety data management
Proactively reviews processes and tools and provides suggestions for improvement and better efficiencies
Complete additional task and projects as assigned by line manager or Head of GPS Operations / designee.

Education:

At least Bachelors degree (or country equivalent) in life sciences / Information technology or other relevant field required
Solid knowledge of global (EU/US/Asia Pac) pharmacovigilance requirements and practices required
Minimum of 7 years of relevant experience in IT / Safety / Clinical Research / Pharmacovigilance overall with at least 3 years of proven experience with safety database systems (e.g. ARGUS or ArisG) including workflow management
Equivalent and adequate combination of education and experience or proven practical expertise in all of the required skills

Knowledge, Skills, Abilities:

Good knowledge of relevant pharmacovigilance regulatory requirements and guidance documents (including Europe, US, Japan)
Adequate computer skills in all current office applications
Proficiency with Excel is required, experience with SQL is a plus
Proficiency in Safety Database systems (e.g. Argus) and knowledge of other technical systems applicable to Safety /Pharmacovigilance (e.g. E2B gateway, safety signal detection tools and systems).
Proficiency in electronic systems commonly used for Safety / PV, like for data visualization and analysis, dashboards
Robust understanding of the end to end process of clinical and post-marketing safety event collection and reporting including of workflow based case processing and MedDRA dictionary
Solid understanding of the development and submission of aggregate safety reports (e.g. DSUR, PSUR)
Solid understanding of the quality management processes, metrics and KPIs
Ability to communicate effectively and collaborate successfully across functions and with vendors
Fluent communication in written and spoken English required
Ability to work independently with minimal oversight and prioritize effectively
Ability to complete multiple complex deliverables within tight timelines
Ability to function effectively in a team environment

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Associate Manager Safety Data and PV Systems

Supply Chain Business Operation Associate Project Manager